CPAP and Physiotherapy for Heart Failure and Sleep Apnea in the Elderly

July 2, 2025 updated by: Weihua Peng

The Impact of Continuous Positive Airway Pressure Combined With Physiotherapy on Ejection Fraction by Ameliorating Sleep Disturbance and Hypoxemia in Elderly Patients With Chronic Heart Failure and Obstructive Sleep Apnea: A Randomized Clinical Trial

This study evaluates whether adding physiotherapy (including herbal medicine, acupuncture, and Tuina massage) to standard continuous positive airway pressure (CPAP) therapy can provide superior benefits compared to CPAP alone for elderly patients suffering from both chronic heart failure (CHF) and obstructive sleep apnea (OSA). This randomized controlled trial aims to determine the combined therapy's efficacy and safety in improving sleep quality, hypoxemia, and cardiac function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The coexistence of chronic heart failure (CHF) and obstructive sleep apnea (OSA) in elderly patients creates a vicious cycle, worsening prognosis. Continuous positive airway pressure (CPAP) is the first-line treatment for OSA, but its efficacy in improving cardiac function in patients with comorbid CHF is debated. This prospective, randomized controlled trial was designed to evaluate the clinical efficacy of a comprehensive intervention combining CPAP with physiotherapy (herbal medicine, acupuncture, and Tuina massage). The study hypothesizes that this combined approach will be more effective than CPAP alone in improving sleep disturbances (assessed by the Pittsburgh Sleep Quality Index and Apnea-Hypopnea Index), alleviating hypoxemia (assessed by arterial blood gas analysis), and favorably modulating left ventricular ejection fraction (EF), thereby offering a superior management strategy for this complex patient population.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhoukou, Henan, China, 461300
        • Fugou County Minzhong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of CHF according to the New York Heart Association (NYHA) functional classification II-IV.
  • Diagnosis of moderate to severe OSA (Apnea-Hypopnea Index [AHI] > 15 events/hour) confirmed by polysomnography.
  • Age ≥ 65 years.
  • Stable clinical condition for at least one month prior to enrollment.
  • Ability to understand and comply with study procedures and provide informed consent.

Exclusion Criteria:

  • Secondary hypertension.
  • Acute myocardial infarction, congenital heart disease, rapid arrhythmias, significant valvular heart disease, cardiomyopathy, or severe hepatic/renal insufficiency.
  • Other respiratory diseases such as chronic obstructive pulmonary disease (COPD), asthma, or pulmonary hypertension.
  • Use of sedative drugs, morphine or its analogues, or other psychotropic medications; cognitive impairment.
  • Received related treatment for OSA or significant changes in CHF medication within the past month.
  • Withdrawal from the study midway.
  • Current participation in other clinical drug trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group: CPAP plus Physiotherapy
In addition to receiving the same CPAP therapy as the control group, patients in this arm received a 3-month physiotherapy regimen. The regimen consisted of: 1) Daily oral administration of a modified herbal decoction (Er Chen Tang with Chang Pu Yu Jin Tang); 2) Acupuncture sessions, once daily, 5 times per week; and 3) Head and occipital Tuina massage.
Device: Continuous Positive Airway Pressure
Using a ResMed S9 AutoSet-S device with a pressure range of 4-20 cmH2O. Used for 5-7 hours per night, at least 5 nights per week, for 3 months.
Drug: Herbal Decoction
A daily dose of a decoction containing Ban Xia, Ju Hong, Shi Chang Pu, Yu Jin, Lai Fu Zi, Fu Ling, Bai Zhi, Cang Er Zi, and Gan Cao, administered orally in two divided doses.
Procedure: Acupuncture
Daily sessions with needle retention for 30 minutes, 5 times per week. Acupoints included Anmian (EX-HN22), Lianquan (CV23), Shanzhong (CV17), Zhongwan (CV12), Kongzui (LU6), Pishu (BL20), Fenglong (ST40), Zusanli (ST36), Yinlingquan (SP9), and Zhaohai (KI6).
Procedure: Tuina Massage
Includes massage techniques applied to the head and occipital region to relax muscles and improve local circulation.
Active Comparator: Control Group: CPAP Alone
Patients received CPAP therapy using a ResMed S9 AutoSet-S device. An optimal pressure or auto-adjusting range was determined via pressure titration. Patients were instructed to use the device for 5-7 hours per night, at least 5 nights per week, for 3 months. All patients also received standard conventional management for CHF and lifestyle advice.
Device: Continuous Positive Airway Pressure
Using a ResMed S9 AutoSet-S device with a pressure range of 4-20 cmH2O. Used for 5-7 hours per night, at least 5 nights per week, for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular Ejection Fraction (EF)
Time Frame: Baseline and 3 months post-treatment
Measured by echocardiography to compare the change in EF from baseline to 3 months post-treatment. EF (%) = (EDV - ESV) / EDV × 100%.
Baseline and 3 months post-treatment
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time Frame: Baseline and 3 months post-treatment
To assess sleep quality. The total score ranges from 0-21, with higher scores indicating poorer sleep quality.
Baseline and 3 months post-treatment
Change in Apnea-Hypopnea Index (AHI)
Time Frame: Baseline and 3 months post-treatment
Measured by overnight polysomnography, defined as the total number of apneas and hypopneas per hour of sleep.
Baseline and 3 months post-treatment
Change in Arterial Oxygen Saturation (SaO2)
Time Frame: Baseline and 3 months post-treatment
Measured via arterial blood gas analysis to assess improvement in hypoxemia.
Baseline and 3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in End-Diastolic Volume (EDV)
Time Frame: Baseline and 3 months post-treatment
Measured by echocardiography.
Baseline and 3 months post-treatment
Change in End-Systolic Volume (ESV)
Time Frame: Baseline and 3 months post-treatment
Measured by echocardiography.
Baseline and 3 months post-treatment
Change in Epworth Sleepiness Scale (ESS) Score
Time Frame: Baseline and 3 months post-treatment
To assess daytime sleepiness. The total score ranges from 0-24, with higher scores indicating greater sleepiness.
Baseline and 3 months post-treatment
Change in Lowest Oxygen Saturation (LSaO2)
Time Frame: Baseline and 3 months post-treatment
Measured by polysomnography.
Baseline and 3 months post-treatment
Change in Longest Apnea Time (LAT)
Time Frame: Baseline and 3 months post-treatment
Measured by polysomnography.
Baseline and 3 months post-treatment
Change in Arterial Partial Pressure of Oxygen (PaO2)
Time Frame: Baseline and 3 months post-treatment
Measured via arterial blood gas analysis.
Baseline and 3 months post-treatment
Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Time Frame: Baseline and 3 months post-treatment
Measured via arterial blood gas analysis.
Baseline and 3 months post-treatment
Incidence of Adverse Reactions
Time Frame: During the 3-month treatment period
Recording of all adverse events experienced during the treatment period, such as nasal itching, nasal dryness, dry eyes, or skin redness.
During the 3-month treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weihua Peng

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 2, 2025

First Posted (Actual)

July 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-B058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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